A Randomized Controlled Trial of a Virtual Reality Based, Approach-avoidance Training Program for Alcohol Use Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 135
- 主要终点
- Changes in alcohol consumption
研究概览
简要总结
The approach-avoidance training program (AATP) has shown preliminary promise as an add-on to standard treatment for alcohol dependence. However, knowledge is lacking as to whether the effectiveness of AATP can be enhanced further when performed in a typical drinking situation. The main aim of this study is to investigate whether approach-avoidance training implemented in a virtual reality bar environment is superior to the classical joystick PC-version of the AATP.
详细描述
The study will be implemented as a randomized controlled trial. A total of 135 consecutively enrolled alcohol use disorder (AUD) patients, recruited from alcohol inpatient clinics in Germany, Poland and Denmark, will be randomized into one of three groups at the start of standard alcohol treatment: group A) stimuli-relevant AATP as usual; group B) stimuli-relevant ATTP in virtual reality, and group C) treatment as usual (TAU; control group). Treatment outcomes will be assessed at pre-treatment, post-treatment and 3-month follow-up. Generalized mixed-models will be applied to compare the trajectories of the groups over time on drinking, craving and impulsiveness outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed written informed consent
- •meeting the diagnostic criteria for alcohol use disorder
- •fluent in language of the participating country (German, Polish or Danish)
- •completion of detoxification (if needed)
- •enrolled in standard treatment within two weeks
排除标准
- •any sensory or motor deficits complicating the provision of the AAT (e.g. color-blindness, fine or gross motor deficits in upper extremities)
- •meeting diagnostic criteria for other substance use disorders
- •severe psychiatric or neurological illness (e.g. psychotic disorders, mental retardation, dementia) or terminal somatic illness
结局指标
主要结局
Changes in alcohol consumption
时间窗: at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)
Alcohol consumption measures will be derived from the Timeline Followback (TLFB). The TLFB method involves using a calendar to identify alcohol consumption patterns in terms of number of drinks per day during the last 30 days. One drink is defined as 12 grams of ethanol. The Visual Analogue Scale (VAS) comprises single items used to measure the degree of alcohol cravings on scales ranging from 0-100, with 0 representing no cravings and 100 an extreme degree of cravings. The scale is presented visually on a ruler, and the individual will be requested to report the frequency, mean level and the peak level of cravings experienced during the last 30 days.
次要结局
- Changes in alcohol abstinence self-efficacy(at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test))
- Changes in impulsivity(at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test))
- Changes in depression severity(at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test))
- Changes in alcohol-related craving(at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test))